Continuous Bupivacaine Infusion Following Colonic Surgery
Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery
調査の概要
詳細な説明
Patients undergoing abdominal surgery will be randomized to one of two groups.
Group 1: Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Group 2: Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
All patients will be premedicated with IV midazolam up to 5 mg. On arrival to the operating room, a fluid bolus of 10 ml/kg/h will be administered before induction of anesthesia.
Those randomized to local wound perfusion will receive the local anesthetic or placebo via the ON-Q pain management system. At the end of surgery a catheter will be positioned in the subcutaneous layer of the wound, leaving via a separate stab incision. The wound closure will then be completed.
A loading dose of local anesthetic solution, 20 ml lidocaine 1% plus 20 ml bupivacaine 0.5%, or, the same amount of placebo will be injected into the wound before the patient leaves the operating room. Thereafter bupivacaine 0.5% alone or placebo will be injected continuously into the wound at a flow rate of 2 ml/h for 24 hours.
Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively with a polygraphic-type tissue oxygen sensor positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients' upper arm after induction of anesthesia.
Postoperative pain relief will be maintained by patient-controlled analgesia (PCA) with morphine (2mg bolus, 6-minute lock-out) and with local anesthetic wound perfusion.
Patients will be given supplemental oxygen via a face mask at a rate of 2 L/min. Additional oxygen will be given as necessary to maintain an oxygen saturation > 95%.
An observer blinded to group assignment will perform all the postoperative evaluations.
Patient chart review will be undertaken to screen for evidence of surgical wound infection. The presence of infection will be determined by review of the attending surgeon's documentation in the patient's chart.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18-80 years of age.
- The patient has provided written informed consent.
- The patient is scheduled for abdominal surgery.
- The patient has an ASA of I, II, or III.
- The patient understands the explanation of the protocol.
Exclusion Criteria:
- Patients aged < 18 and > 80 years.
- History of diabetes mellitus.
- History of congestive heart failure.
- History of peripheral vascular disease.
- History of smoking.
- History of Dysautonomia.
- History of thyroid disease.
- Susceptibility to malignant hyperthermia.
- History of morbid obesity.
- History of fever
- History of infection.
- Contraindication to the placement of an arterial line; e.g., Raynaud's disease.
- The patient declines participation.
- Any patient the investigator feels is not a candidate for this study.
- Any patient with a history of known alcohol, analgesic, or narcotic substance abuse within two years of screening.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:bupivacaine
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
|
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
他の名前:
|
プラセボコンパレーター:Placebo
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
|
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
tissue oxygenation
時間枠:24 hours post surgery
|
averge tissue oxygenation on wound healing after abdominal surgery
|
24 hours post surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Verbal rating scales (VRS)
時間枠:24 hours post surgery
|
0 -10 scale with 0 = no pain and 10 = worst pain
|
24 hours post surgery
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
腹部外科の臨床試験
-
Dong Yangわからない腹腔鏡補助下手術 | 切開を行わない全腹腔鏡手術(Natural Orifice Transluminal Endoscopic Surgery、NOSES)中国